Pharmaceutical Subject Matter Expert – AI Model Evaluation

This is a fully remote position, open to applicants in United States, +3 more countries.

📋 Description

• Assess AI-generated pharmaceutical content for scientific, technical, and regulatory precision, thoroughness, consistency, and compliance.

• Examine information pertaining to quality systems, manufacturing, validation, submissions, development, and adherence to regulations.

• Evaluate whether AI-generated conclusions are backed by scientific principles, regulatory requirements, and industry best practices.

• Detect unsupported claims, technical inaccuracies, lack of context, and flawed reasoning.

• Refer to FDA standards, GMP regulations, ICH guidelines, and accepted practices within the pharmaceutical industry.

• Deliver expert feedback, clarify findings, pinpoint enhancements, and suggest accurate corrections.

• Utilize project-specific evaluation criteria, scoring guidelines, and quality benchmarks.

• Conduct independent evaluations using designated online platforms while adhering to project timelines.

⛳️ Requirements

• A minimum of four years of relevant professional experience within the regulated pharmaceutical or biotechnology sector in the US.

• A Bachelor's degree or higher in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Engineering, Regulatory Affairs, or a related field.

• Strong expertise in at least one of the specified pharmaceutical specialties.

• Familiarity with FDA regulations, GMP requirements, and pertinent ICH guidelines, including applicable segments of ICH Q7-Q12.

• Proficiency in critically evaluating scientific, technical, and regulatory information.

• Strong analytical, research, and problem-solving skills.

• Exceptional written English communication abilities.

• Confidence in reviewing intricate information and articulating technical conclusions.

• Comfortable utilizing digital platforms, web-based applications, and online research tools.

• Capability to work independently, adhere to detailed instructions, and meet established quality benchmarks.

• Must be familiar with and comfortable in a task-based freelance engagement model.

• Preferred: PharmD, PhD, or other advanced scientific qualifications.

• Preferred: Experience in preparing or reviewing regulatory submissions (IND, NDA, BLA, ANDA, MAA, or equivalent).

• Preferred: Experience within FDA-regulated manufacturing, quality, compliance, validation, or development environments.

• Preferred: Experience conducting quality reviews, regulatory audits, or evaluations of scientific content.

• Preferred: Experience in technical writing, structured reviews, or compliance assessments.

• Preferred: Familiarity with AI model evaluation, prompt review, rubric development, or data annotation.

• Preferred: Previous participation in scientific, regulatory, quality, or technical content assessment activities.

🏝️ Benefits

• Opportunity to work remotely from an eligible location.

• Flexible, variable schedule based on assignments.

• Project-based assignments providing supplemental-income flexibility.

• Chance to contribute to cutting-edge AI technologies.

• Experience participating in AI evaluation initiatives.

• No prior AI background required.